Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT00874133
Status:
TERMINATED
Last Update Posted:
2013-12-06
First Post:
2009-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Acupuncture on Symptoms, Gastric Emptying Rate and Glucose Control in Patients With Diabetic Gastroparesis
Sponsor:
Rabin Medical Center
Organization:
Study Overview
Official Title:
The Effect of Acupuncture on Symptoms, Gastric Emptying Rate and Glucose Control in Patients With Diabetic Gastroparesis
Status:
TERMINATED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Completed due to low number of eligible patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diabetes affects 5.8% of the adult population in Israel (1). Gastroparesis is a syndrome characterized by delayed gastric emptying in the absence of mechanical obstruction of the stomach.Treatment with acupuncture has been described as effective in improvement of symptoms in patients with gastroparesis in a number of patient series. However, this treatment approach has not been tested by means of a controlled randomized clinical study, and neither has the connection between improvement of symptoms and the anatomical-physiological effect of the treatment, if ever, assessed.This study will test the efficacy of motilium (20 mg thrice daily) as compared to acupuncture treatment on the following subjective and objective parameters of 30 patients with diabetic gastroparesis and impaired glucose control:
1. To compare the degree of GCSI scores improvement before and after treatment with motilium or acupuncture using a validated questionnaire.
2. To determine the effect of treatment with motilium or acupuncture on gastric emptying rate.
3. To determine the effect of treatment with motilium or acupuncture on glycemic control.
4. To compare the quality of life before and after treatment with motilium or acupuncture using the Short Form-36 (SF-36).
1. To compare the degree of GCSI scores improvement before and after treatment with motilium or acupuncture using a validated questionnaire.
2. To determine the effect of treatment with motilium or acupuncture on gastric emptying rate.
3. To determine the effect of treatment with motilium or acupuncture on glycemic control.
4. To compare the quality of life before and after treatment with motilium or acupuncture using the Short Form-36 (SF-36).
Detailed Description:
This is a randomized, comparative, pilot study, which will compare two treatments: acupuncture treatment vs. treatment with motilium in 30 diabetic patients with impaired glucose control and gastroparesis.
All patients who meet inclusion criteria will undergo gastric scintigraphy and upper endoscopy to assess the presence of gastroparesis and to rule out gastric outlet obstruction. At baseline, all enrolled patients will fill out the Gastroparesis Cardinal Symptom Index (GCSI), the Quality of life questionnaire (SF-36). Subsequently, patients will be randomized to 20 mg motilium thrice daily and after 1 month wash-out period to acupuncture treatment, each treatment will last 12 weeks.
After treatment, patients will undergo a second gastric scintigraphy and will complete the GCSI and the SF-36.
Fasting blood glucose concentrations and HbA1c levels will be determined at the beginning and at the end of the study and at 6 months later as well.
End Points:
Primary: Level of improvement of gastric emptying rate, and improvement in blood glucose levels at the end of treatment, in comparison with tests before treatment.
Secondary: Level of improvement in scores of severity of gastroparesis related symptoms, with quality of life indicators, in comparison with tests before treatment; also, the number of visits to family doctors/diabetic clinics/emergency rooms, as well as use of the medications resulting from diabetic complications will be investigated.
All patients who meet inclusion criteria will undergo gastric scintigraphy and upper endoscopy to assess the presence of gastroparesis and to rule out gastric outlet obstruction. At baseline, all enrolled patients will fill out the Gastroparesis Cardinal Symptom Index (GCSI), the Quality of life questionnaire (SF-36). Subsequently, patients will be randomized to 20 mg motilium thrice daily and after 1 month wash-out period to acupuncture treatment, each treatment will last 12 weeks.
After treatment, patients will undergo a second gastric scintigraphy and will complete the GCSI and the SF-36.
Fasting blood glucose concentrations and HbA1c levels will be determined at the beginning and at the end of the study and at 6 months later as well.
End Points:
Primary: Level of improvement of gastric emptying rate, and improvement in blood glucose levels at the end of treatment, in comparison with tests before treatment.
Secondary: Level of improvement in scores of severity of gastroparesis related symptoms, with quality of life indicators, in comparison with tests before treatment; also, the number of visits to family doctors/diabetic clinics/emergency rooms, as well as use of the medications resulting from diabetic complications will be investigated.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: